Kornimate/medical-research-clean huggingface dataset:
experiences reported by siblings of children hospitalized in the picu

Conditions: Intensive Care Pediatric

Summary: the care for a child in pediatric intensive care is recognized as a traumatic experience for the patient and their entourage. the needs and feelings of parents are relatively well supported in the literature. however, there is still too little data concerning siblings, who can nevertheless be impacted by this difficult life experience. the study consists of conducting two semi-structured interviews with siblings of children hospitalized in pediatric intensive care at necker-enfants malades hospital and robert debré hospital. the first interview will take place during the stay in intensive care, the second one 1 month after discharge from pediatric intensive care.

the care for a child in pediatric intensive care is recognized as a traumatic experience for the patient and their entourage. the needs and feelings of parents are relatively well supported in the literature. however, there is still too little data concerning siblings, who can nevertheless be impacted by this difficult life experience. the study consists of conducting two semi-structured interviews, with an estimated duration of 15 to 30 minutes, with siblings of children hospitalized in pediatric intensive care at necker-enfants malades hospital and robert debré hospital. the first interview will take place during the stay in intensive care, the second 1 month after discharge from pediatric intensive care. the study will concern children and adolescents aged 10 to 18 years old because this is a population at risk in this situation. concepts of illness, death and its irreversible nature evolve during childhood. by definition, there are three major stages which are: 0-6 years; 7-11 years; 10-18 years. for older children (\> 10 years) these definitions are well established and they would be more at risk of presenting psychiatric disorders later (post-traumatic stress disorder, major depressive syndrome, etc.).

Eligibility criteria:
inclusion criteria: * children and adolescents aged 10 to 18 years * whose sister or brother is hospitalized in pediatric intensive care at necker-enfants malades hospital or robert debré hospital * holders of parental authority and children or adolescents informed and consenting to participate in the study exclusion criteria: * death of patients * language barrier (french not mastered) * inability to participate in a semi-structured interview (intellectual disability)

Keywords: pediatric intensive care hospitalisation siblings semi-structured interviews post-traumatic stress disorder major depressive syndrome
montreal heart attack readjustment trial (m-hart)

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia

Summary: to examine the impact of a monitoring and social support intervention upon survival of myocardial infarction patients.

background: despite evidence that social support and various aspects of negative affect may influence prognosis after a myocardial infarction, the impact of psychosocial supportive interventions had not been demonstrated. further, little was known about the impact of psychosocial and/or interventions among women patients. previous work by nancy frasure-smith and colleagues suggested that a one-year post-myocardial infarction program of monthly telephone monitoring of psychological stress symptoms, coupled with home nursing visits for patients reporting high stress levels, had an impact on one-year cardiac mortality and long-term myocardial infarction recurrences among men. however, methodological difficulties prevented drawing firm conclusions. a trial which corrected for these difficulties was conducted involving 948 post-myocardial infarction patients. however, the project was too small to study enough patients to assess program impact separately for men and women. the trial was supported by canadian sources. the nhlbi supplemented the study in order to expand the sample size from 948 patients to 1,376 patients to allow gender analysis. design narrative: randomized, with a multi-hospital design. at the time of discharge from the hospital following a documented myocardial infarction, patients were randomized to treatment and control groups. the control group received usual care from their physicians. in addition to usual care, treatment patients were phoned monthly and responded to a standardized index of psychological symptoms of stress. those with high stress levels received home nursing visits to reduce their stress. patients in both groups took part in three interviews: in the hospital, at three months, and at one year post-discharge. interviews assessed depression, anxiety, anger, self-perceived stress, social support, medication compliance, and cardiac risk factors. salivary cortisol, a physiological indicator of stress, was assessed on the evening following each interview. indicators of residual myocardial infarction, ischemia, and arrhythmias were obtained from hospital charts. outcome data were obtained from hospital charts, death certificates, and quebec medicare data and were blindly classified by study cardiologists.

Eligibility criteria:
men and women myocardial infarction patients.
telerehabilitation, core stability exercises and hereditary ataxia (trcore-ataxia)

Conditions: Hereditary Ataxia; Spinocerebellar Degenerations; Cerebellar Ataxia

Summary: hereditary ataxias (ha) are a heterogeneous group of degenerative diseases of the cerebellum, brain stem and spinal cord. people who suffer from ah, among other symptoms, present deficiencies in the stability of the trunk, which leads to an alteration in postural control, with a strongly influential factor in the loss of balance and gait disorders. improving the functionality of these physical aspects can help reduce the rate of falls, increase autonomy and quality of life for people with ha. evidence suggests that rehabilitation strategies based on core stability exercises (cse) are effective in improving balance and postural control in several neurological diseases, such as stroke. however, there is little evidence with people with ha. in a previous study carried out by researchers of this project, in which an eec exercise program was piloted at home, low adherence to treatment was perceived due to the little follow-up that was given to the participants. therefore, including telerehabilitation in these programs would increase follow-up and could influence adherence.


Eligibility criteria:
inclusion criteria: * suffer from degenerative ha at any stage of the disease (spinocerebellar ataxia, friedreich's ataxia, sporadic idiopathic cerebellar ataxia and neurodegenerative diseases where ataxia is the dominant symptom). * adults over 18 years of age. * be able to use a computer or mobile phone (it will be evaluated using the dile scale) * have an internet connection. exclusion criteria: * suffer from other neurological diseases and inability to follow simple instructions. - * suffering from a musculoskeletal injury that prevents you from performing the exercises. * being unable to maintain standing for more than 10 seconds without support (assessed with item 2 on the sara scale).

Keywords: spinocerebellar degenerations telerehabilitation exercise
phototherapy in young people with depression

Conditions: Depression

Summary: bright light therapy is an established treatment pathway for sleep and circadian disorders and evidence suggests that it has antidepressant effects. the underlying mechanisms of these antidepressant effects are not fully understood and results from previous studies are somewhat variable. one of the important limitations of previous depression studies has been the heterogeneity of samples in which bright light therapy has been administered. the main aim of this study is to evaluate whether the antidepressant effects of phototherapy in young persons with depression are modulated by changes in the sleep-wake cycle. we hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant response to phototherapy and that the magnitude of changes in depressive symptoms across the course of the intervention will correlate with changes in the sleep-wake cycle.


Eligibility criteria:
inclusion criteria: 1. quick inventory of depressive symptomatology score \> 6; 2. first episode of depression before age 25; 3. currently engaged in, or about to start treatment for an affective disorder at a mental health clinic. exclusion criteria: 1. evidence of other sleep, neurological or primary medical conditions that could explain the current depression and/or contribute to sleep-wake dysfunction; 2. other primary psychiatric disorders aside from anxiety disorders; 3. significant alcohol or other substance dependence; 4. use of medications that affect sleep, circadian rhythms, or alertness within the past month (participants stabilized on an antidepressant medication, stimulants, lithium or melatoninergic agents will not be excluded from the study); 5. use of medications that may interact with light to produce a photoallergic reaction; 6. eye or skin condition which may interact with bright light exposure; 7. regular shift-work within 60-days prior to entry into the study; 8. recent transmeridian travel.

Keywords: phototherapy light depression sleep and circadian disturbances youth
integrative korean medicine treatment for inpatients with failed back surgery syndrome: a retrospective study with survey

Conditions: FBSS; Medicine, Korean Traditional

Summary: the purpose of this study is to reveal the effectiveness and safety of integrative korean medicine for failed back surgery syndrome(fbss) by observing inpatients treated with integrative korean medicine. this study is a retrospective observational study. the subjects for study are patients diagnosed with fbss and who have been admitted to four jaseng hospital of korean medicine (gangnam, bucheon, daejeon, and haeundae) for 2015.01.01-2019.12.31. medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. the survey questions are numeric ratinc scale (nrs), oswestry disability index(odi), quality of life, and patient global impression of change (pgic), etc.


Eligibility criteria:
inclusion criteria: 1. patient who has a past history of lumbar surgery and has been hospitalized for persistent or recurrent pain and discomfort 2. patient hospitalized for more than a week 3. pateints above 19 years old and below 70 years old 4. patients who have agreed to participate the study exclusion criteria: 1. patients who have been diagnosed with certain serious diseases that may cause back pain or limb pain (tumor metastases to the spine, spinal infections, ankylosing spondylitis(as), acute fractures, spinal dislocation and so on) 2. patients who have progressive neurological defects or severe synchronic neurological symptoms 3. the cause of the pain is soft tissue problems(tumor, fibromyalgia, rheumatoid arthritis, gout) and not related to spine 4. patients who have been diagnosed with certain serious diseases that may cause disturbance to interpretation of conclusion (cardiovascular problems, kidney disease, diabetic neuropathy, dementia, epilepsy, and so on) 5. patients who took steroids, immunosuppressants, psychiatric medications, or other drugs deemed inappropriate by researchers during hospitalization 6. patient who has visited this medical institution within the last six months. 7. patients deemed unable to participate in the clinical research by other researchers 8. patients who haven't agreed to participate the study

Keywords: acupuncture therapy herbal medicine
controlling hypertension outcomes by improved communication & engagement

Conditions: Hypertension; Stroke

Summary: this randomized control study tested the feasibility of two communication enhancement interventions: one with veterans who had a stroke and demonstrated poorly controlled hypertension; the other with va primary care providers who provided routine outpatient medical care to these veterans. this study intervened with both members of the provider-patient dyad in an attempt to improve the self-management of hypertension by improving communication during visits to the va outpatient clinic, specifically by enabling veterans to communicate their questions and concerns about chronic disease self-management to their providers more effectively, and to help providers improve their ability to communicate more effectively with this population of veterans.

the communication intervention had two goals; (a) coaching to enhance veteran's abilities to communicate their questions and concerns about self-management for hypertension to their physician; and (b) improving provider's communication skills for enhancing and encouraging self-management of hypertension. a health educator met with each participating veteran in the intervention arm prior to the 2nd visit to develop a plan for enhancing communication about self-management of hypertension. the pi provided the four habits communication training to the 5 primary care providers in the intervention arm. two clinic visits between each participating provider-patient pair were videotaped and coded. this project had a goal of enrolling 10 va primary care providers to participate in the randomized control trial and 30 veterans (3 veterans from the panel of each of the 10 participating providers) who had a stroke and now demonstrated poorly controlled hypertension. the study evaluated the difference between the two groups, and compared the content of the provider-patient conversations around hypertension management.

Eligibility criteria:
inclusion criteria: veteran: * veteran is a patient of the enrolled provider * history of prior stroke * poorly controlled hypertension with at least one measurement \>140/90 mm hg in the past 12 months * complete a 6-item screen for cognitive and language impairment with a score of 3 or higher * sign the va media consent for use of picture and/or voice provider: * primary care provider, medicine service * sign va media consent for use of picture and/or voice exclusion criteria: * life expectancy is less than 6 months * non-english language patients * inability to provide informed consent

Keywords: hypertension physician-patient relations communication
a study of the apricitycare program for early detection and management of treatment-related adverse events in patients with cancer

Conditions: Metastatic Cancer

Summary: to evaluate the rate of therapy discontinuation due to toxicity (side effects) among participants with cancer using apricitycare. investigators want to learn if identification of early clinical signs of iraes with timely treatment can prevent severity progression and reduce treatment discontinuation.

primary objective • to determine the rate of therapy discontinuation due to toxicity among patients using apricitycare. secondary objectives • to evaluate time the ease and experience of patient use of apricitycare (i.e., patient engagement) in reporting symptoms during their systemic cancer treatments. furthermore, the frequency of patient symptom reporting via check-in to apricitycare will be evaluated, as will the time taken to respond and engage patients after they report toxicity or other adverse events via apricitycare.

Eligibility criteria:
inclusion criteria: * age 18 years of age or older * confirmed diagnosis of cancer * part 1 (run-in phase): only patients with prostate, kidney, and/or bladder cancer will be enrolled with either localized or metastatic disease. * part 2 (expansion phase): metastatic patients will be enrolled. note, evaluable metastatic patients from ppart 1 will be counted in cohort a as described in section 8.4. * planned to receive systemic anti-cancer therapy * ability to understand and the willingness to sign a written informed consent document * ability to speak, read, and understand one of the following languages: english, spanish, mandarin and cantonese chinese * ownership of a smartphone and willingness to use it as outlined by the protocol and described in the icf exclusion criteria: - have any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study (pregnancy is not exclusionary and pregnant women will be permitted to enroll in the study).
total knee arthroplasty (tka) cemented versus cementless

Conditions: Osteoarthritis, Knee

Summary: the aim of the study is to analyse and to compare the quality of fixation of a femoral implant with or without cement. one hundred thirty patients will be operated on and included with 2 groups, the first one with tka all cemented and the second one with tka with a cementless femoral implant. the study criteria include the iks (international knee society) score and the analysis of a radiolucent line at the femur. patients will be reviewed at 2, 6 and 12 months.


Eligibility criteria:
inclusion criteria: * osteoarthritis (medial and/or lateral femoro-tibial arthritis and/or patellofemoral arthritis) * indication of surgical treatment by total knee arthroplasty * age between 50 and 90 years * acceptance and signature to participate exclusion criteria: * rheumatoid or other inflammatory arthritis * association with other surgical procedure (osteotomy) * range of motion inferior to 90° * previous knee surgery (except arthroscopy)

Keywords: knee arthroplasty femoral loosening total knee arthroplasty
time interval between tvt and first void (tibt) study

Conditions: Stress Urinary Incontinence

Summary: the primary aim of this study is to compare, in women undergoing tension-free vaginal tape (tvt) insertion under sedation and local anaesthetic infiltration, the time interval of first void following surgery between a group of patients who received intravenous fluids to those who did not.

urinary incontinence is a global condition and its prevalence increases with age. it impairs quality of life of patients and has a significant burden on the health care system. stress urinary incontinence (sui) is defined as involuntary leakage of urine when there is an increase in pressure on the bladder, i.e. during exercise, coughing or sneezing. it is the commonest form of urinary incontinence and affects around 50% of women with symptoms of incontinence. the development of mid urethral tapes (e.g. the tension free vaginal tape \[tvt\]) in 1998 has greatly changed clinical practice. the introduction of tvts has reduced the average length of hospital stay for patients undergoing surgical treatment of sui by over 50%. as a result, the hospital bed occupancy for the treatment of sui has decreased by a similar amount. studies have shown it to have similar effectiveness to the main alternative surgical treatments in sui. in gloucestershire royal hospital, we perform the procedure as a daycase with local anaesthetic infiltration under sedation. routine cystoscopy is performed as a part of the procedure to exclude bladder trauma. the bladder is emptied at the end of procedure. patients are then allowed to drink as normal and post void residuals are checked before discharge to rule out any problems emptying the bladder. it has been observed that the major limiting factor in early discharge of patients is the time to first void following surgery. as the patients are starved for surgery, they are often dehydrated and therefore require enough oral fluids to rehydrate and fill their bladder in order to void. if we can somehow reduce this waiting period, we can discharge patients sooner improving their experience with the surgery. we would like to examine whether filling up the bladder intra-operatively with intravenous fluid will reduce this time limiting step.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study exclusion criteria: * tvt performed under general or spinal anaesthetic * women under the age of 18 years * women unable to give informed consent * tvt performed in addition to another procedure * women not suitable for a fluid challenge due to co-morbidities.

Keywords: tension-free vaginal tape
project nightlight: efficacy and system acceptance of dinner/night vs. 24hr closed loop control

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to use an investigational type of technology called closed-loop control (clc) medical platform system to help control blood sugar in people with type 1 diabetes mellitus in a home setting.

the clc is an "artificial pancreas" (ap) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with type 1 diabetes. the system modulates insulin to keep blood glucose in a targeted range. the clc will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.these functionalities occur in a randomized cross-over design, each occurring for 8 weeks. these modalities are: 1. sap=sensor-augmented pump only 2. uss+sap (d)= evening and overnight closed-loop control=sap during day and clc starting at dinner and continuing overnight 3. uss+clc (d)= 24/7 closed-loop control=24-hour day and night closed loop control

Eligibility criteria:
inclusion criteria: * type 1 diabetes for at least one year * using insulin for at least 1 year * an insulin pump for at least 6 months * willingness to switch to lispro (humalog) or aspart (novolog) if using glulisine (apidra). exclusion criteria: * a medical condition or being been treated with medications that might interfere with the study

Keywords: closed-loop control (clc) sensor-augmented therapy (sap) uss virginia continuous glucose monitor (cgm) insulin pump artificial pancreas (ap)
three-way-cross-over study to evaluate safety and pharmacokinetics of lacosamide in healthy japanese and chinese males

Conditions: Healthy Volunteers

Summary: the purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in healthy male chinese and japanese subjects.


Eligibility criteria:
inclusion criteria: * healthy chinese or japanese volunteers exclusion criteria: * subject has participated or is participating in any other clinical studies of lacosamide within the last 3 months * subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any psychological or emotional problems, a drug/alcohol abuse, abnormal diet, having abnormal safety parameters)

Keywords: vimpat pharmacokinetics healthy japanese male healthy chinese male